Effects of Triclosan-coated Sutures in Cardiac Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01212315
• Date of registration: 29/09/2010
• Primary sponsor: Sahlgrenska University Hospital, Sweden
• Public title: Effects of Triclosan-coated Sutures in Cardiac Surgery
• Scientific title: Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs
• Date of first enrolment: March 2009
• Target sample size: 392
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01212315
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Sweden

Contacts

• Name: Anders Jeppsson, MD PhD
• Affiliation: Sahlgrenska Univerity Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients undergoing elective CABG at Sahlgrenska University Hospital with intended
use of saphenous vein graft are included.

Exclusion Criteria:

- Patients with on-going sepsis or septicaemia, bacterial infections or known allergy
to triclosan are excluded.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Wound Infection

Intervention(s)

Device: Triclosan coated sutures

Primary Outcome(s)

Proportion of subjects with leg wound infection. [Time Frame: Within 60 days after heartsurgery]

Secondary Outcome(s)

Culture-proven and antibiotic-treated wound infection after heart surgery [Time Frame: Within 60 days after heart surgery]

Secondary ID(s)

001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors